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. 2012 Dec 17;6:429–464. doi: 10.2147/BTT.S36707

Table 9.

Characteristics of included monotherapy studies

Study Disease severity Treatment and dose Treatment group for analysis Number of patients randomized Mean age, years Mean disease duration, years Withdrawals, %
Johnsen et al73 Active RA despite DMARD DAS28 CRP 6.0–6.2 ETN 25 mg twice weekly ETN 2 × 25 mg/week 26 50.5 (median) 12.5 (median) 12
ETN 50 mg twice weekly ETN 2 × 50 mg/week 51 55.0 (median) 15.0 (median) 16
Miyasaka74 Active disease despite prior treatment with ≥1 DMARD Placebo every other week PLA 87 53.4 8.4 59
ADA 20 mg every other week ADA 20 mg/2 weeks 87 54.8 10.0 38
ADA 40 mg every other week ADA 40 mg/2 weeks 91 56.9 9.9 35
ADA 80 mg every other week ADA 80 mg/2 weeks 87 54.3 9.5 25
Moreland et al80 Active disease despite 1–4 conventional DMARDs Placebo PLA 44 55 77% had duration >5 years 48
ETN 0.25 mg/m2 ETN 0.25 mg/m2 46 54 39
ETN 2 mg/m2 ETN 2 mg/m2 46 52 22
ETN 16 mg/m2 ETN 16 mg/m2 44 52 7
Moreland et al75 Active RA (advanced) despite DMARD (>90% MTX exposed) Placebo PLA 80 51 12 33
ETN 10 mg sc twice weekly ETN 2 × 10 mg/week 76 53 13 32
ETN 25 mg sc twice weekly ETN 2 × 25 mg/week 78 53 11 24
Nishimoto et al77 Active, relatively severe disease despite ≥ 1 DMARD Placebo PLA 53 Median 53.0 Median 8.4 47
TOC 4 mg/kg every 4 weeks TOC 4 mg/kg/4 weeks 54 Median 53.5 Median 7.3 4
TOC 8 mg/kg every 4 weeks TOC 8 mg/kg/4 weeks 55 Median 56.0 Median 8.3 7
Nishimoto et al76 Active disease despite prior MTX for ≥8 weeks DAS28 6.1 MTX 8 mg/week MTX 66 50.8 8.7 48
TOC 8 mg/kg iv every 4 weeks TOC 8 mg/kg/4 weeks 61 52.6 8.5 11
van de Putte et al79 Active RA despite ≥ 1 DMARD DAS28 7.0–7.1 Placebo PLA 70 50.2 9.4 33
ADA 20 mg weekly ADA 20 mg/week 72 53.7 10.4 14
ADA 40 mg weekly ADA 40 mg/week 70 52.6 10.0 17
ADA 80 mg weekly ADA 80 mg/week 72 53.2 10.1 8
van de Putte et al78 Active long-standing severe RA despite ≥ 1 DMARD DAS 7.07 Placebo PLA 110 53.5 11.6 56.4
ADA 20 mg every other week ADA 20 mg/2 weeks 106 53.1 9.3 35.8
ADA 20 mg weekly ADA 20 mg/week 112 54.4 11.3 29.5
ADA 40 mg every other week ADA 40 mg/2 weeks 113 52.7 10.6 28.3
ADA 40 mg weekly ADA 40 mg/week 103 51.8 11.9 14.6

Notes: Combe et al,42 Edwards et al,81 Kameda et al,46 Keystone et al,82 Maini et al,51 and van Riel et al47 – characteristics as per Table 3; treatments in bold are treatments of interest (licensed doses); PLA is the reference treatment.

Abbreviations: ADA, Adalimumab; DAS, Disease Activity Score; DMARD, disease-modifying anti-rheumatic drugs; ETN, etanercept; MTX, methotrexate; PLA, placebo; RA, rheumatoid arthritis; TOC, Tocilizumab.